Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00471

2 Trial Registration Date

2015-08-25

i Registration Status

Prospective

3 Secondary IDs

CRE2014.672

4 Source(s) of Funding

HMRF Commisioned Grant 2015-19

5 Primary Sponsor

HMRF

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

C/-Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

C/-Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Detection and characterization of novel / unrecognized microbial pathogens associated with unexplained severe sepsis

10 Public Title

Culture negative severe sepsis

i Public Title in Chinese 研究名稱

導致不明原因的重症膿血症的新/未知病原微生物相關的檢測以及特性

11 Short Title (Optional)

Culture negative severe sepsis

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-03-26

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Sepsis

15 Intervention

i Types of intervention

Other

Please specify

Observational study

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

N/A

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) Adult (≥ 18 years), male or female patients with severe sepsis admitted to ICU of Prince of Wales Hospital. Sepsis will be defined according to the 1992 American College of Chest Physicians (ACCP)/Society of Critical Care Medicine (SCCM) Consensus Conference criteria (i.e. sepsis with at least one organ dysfunction).

ii Exclusion Criteria

(1) ICU re-admission during the same hospital stay
(2) Patients (or next-of-kin) refusal of consent

iii Age Minimum

18

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-09-10

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Identication of source of pathogen in blood

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-08-25